Safety and Effectiveness of MD-Small Joints Collagen Medical Device for Treating Symptomatic Thumb Base Osteoarthritis in Adults

What this Trial Is About

Collagen is a key structural protein in the body, especially found in skin, cartilage, bones, and joints. Researchers are evaluating an injectable medical device called MD-Small Joints Collagen Medical Device, which contains type I collagen from swine, to study its safety and performance in treating symptomatic thumb base osteoarthritis rhizarthrosis. This condition causes joint pain and instability, and the study aims to see if the treatment can reduce pain and improve joint function. Participants will receive a series of five injections of the collagen device around and inside the affected thumb joint. The first three injections are given both inside and around the joint, while the last two are only around the joint. These injections are spaced weekly, starting at enrollment. The study is designed as a multicenter clinical investigation with assessments at baseline, 3 weeks, 6 weeks, and 16 weeks, with the final visit occurring 12 weeks after treatment ends. During the study, participants will be monitored closely with evaluations including pain measurement using the Visual Analogue Scale VAS, functional assessments like the Disability of the Arm Shoulder and Hand DASH score, the Functional Index for Hand Osteoarthritis FIHOA, and pinch strength tests. Researchers will also track analgesic use and any adverse events throughout the study. The main goal is to determine if the collagen treatment helps reduce pain by at least 30% six weeks after starting injections compared to baseline.

Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS